Evaluating primary end points in peanut immunotherapy clinical trials - 07/02/19
, Carmelo Escudero, MD a, b, c, Silvia Sánchez-García, MD, PhD a, b, c, María Dolores Ibáñez, MD, PhD a, b, c, Brian P. Vickery, MD dAbstract |
Food immunotherapy has been the focus of several allergy research initiatives over the last decade. Although many questions remain unanswered, the evidence suggests that this treatment might be available in the near future outside clinical trials. Additionally, pharmaceutical companies, in light of promising early-stage results, have shown interest in developing commercially available products, thus increasing the likelihood that new immunotherapy treatments will be introduced, especially for peanut allergy. Given this optimistic scenario and given the prospect of rigorously developed products for peanut allergy treatment, each allergist will need to understand the specificities of these treatments and their expected efficacy and adverse event profiles. Thus it is imperative that allergists understand the differences in efficacy between the different management options, as well as how the end points are measured in the relevant literature. However, given the significant heterogeneity detected among food immunotherapy trials, this task might not be as straightforward as desired. This article aims to dissect how primary efficacy end points are defined and assessed to facilitate understanding of the design of these trials and the potential effect that this variation might have on the reported outcomes.
Le texte complet de cet article est disponible en PDF.Key words : Peanut allergy, food immunotherapy, desensitization, sustained unresponsiveness, randomized clinical trial, food allergy, oral food challenge
Abbreviations used : AIT, DBPCFC, DBRPCT, EAACI, MP, OFC, OIT, SLIT, SU
Plan
| Disclosure of potential conflict of interest: P. Rodriguez del Rio received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, and Spanish Society of Allergology and Clinical Immunology Foundation and reports honoraria for consultancy and/or advisory board and/or lectures from ALK-Abelló, HAL-Allergy, FAES Pharma, LETI Pharma, Merck, Aimmune, Allergy Therapeutics, MEDA Pharma, and Novartis. C. Escudero received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, Spanish Society of Allergology and Clinical Immunology Foundation, and Aimmune Therapeutics; serves as a consultant for ALK-Abelló, Leti, and Novartis Pharma; and has received lecture fees from Spanish Society of Allergology and Clinical Immunology and Porto University. S. Sánchez-García received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Niño Jesús University Children's Hospital, and Spanish Society of Allergology and Clinical Immunology Foundation; is a consultant for ALK-Abelló and Allergy Therapeutics; and receives lecture fees from Nutricia, Novartis, GlaxoSmithKline, Leti, and Allergy Therapeutics. M. D. Ibáñez receives research funding from the Health Research Fund of Carlos III Health Institute and Aimmune Therapeutics, serves as a consultant for Merck and Novartis, and has received lectures fees from the Spanish Society of Allergology and Clinical Immunology, Leti, Merck, FAES, and MSD. B. P. Vickery is a consultant to Aimmune Therapeutics, reports employment and stock options from Aimmune in the 12 months before publication, is a consultant to the Gerson Lehman Group, and is a member of the Outcomes Research Advisory Board at Food Allergy Research and Education. |
Vol 143 - N° 2
P. 494-506 - février 2019 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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